Obesity combined with knee osteoarthritis (KOA)
Conditions
Interventions
Enogluteutide group:Administer ecnoglutide injection
Placebo group:Administer placebo
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Male or female participants, aged between 18 and 75 years (inclusive) at the time of informed consent. 2.Body mass index (BMI) >= 28 kg/m^2 at screening. 3.The target knee meets the clinical and radiographic diagnostic criteria for knee osteoarthritis established by the American College of Rheumatology (ACR), with moderate radiographic changes corresponding to Kellgren-Lawrence grade 2 or 3. The target knee is defined as the knee with the most severe symptoms at screening. If pain severity is comparable in both knees, the dominant (preferred) knee will be selected as the target knee. 4.The participant has experienced pain in the target knee for more than 12 weeks prior to screening, and reported pain in the target knee on more than 15 days within the past month based on medical history or self-report at screening. 5.The WOMAC pain subscale score (NRS 0-10 scale) of the target knee is between 4 and 9 points (inclusive) at screening and prior to randomization. Participants shall not be informed of the pain score used for eligibility assessment to avoid reporting bias. 6.Participants have a self-reported history of failed weight loss attempts via diet and exercise intervention. 7.Participants fully understand the study objectives, are able to communicate effectively with investigators, and can comprehend and comply with all study requirements.
Exclusion criteria
Exclusion criteria: 1.Has undergone total joint arthroplasty of the target knee; 2.Received arthroscopy of the target knee within 12 months prior to screening; 3. The target knee joint exhibits clinical features and symptoms of other active infections or crystal-induced arthropathy during screening, or has any other active joint disease that may interfere with the evaluation; 4. Target knee joints that have received intra-articular injections of hyaluronic acid or other investigational drugs or biologics within the 3 months prior to screening, or have undergone procedures (such as ablation) resulting in persistent sensory loss in the target knee joint within the 6 months prior to screening; 5. Screening within 30 days of receiving corticosteroid (investigational or marketed) intramuscular or oral injections, or within 90 days of any joint receiving corticosteroid (investigational or marketed) intra-articular injections; 6. Exclude any knee joint with instability within the past 12 months, such as anterior cruciate ligament rupture or recent trauma; 7. History of other potential pathogenic and/or confounding diseases, including Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, inflammatory bowel disease-associated arthritis, sarcoidosis, amyloidosis, or fibromyalgia; 8. Presence of symptomatic hip osteoarthritis during screening (excluding those who have undergone hip replacement surgery); 9. There are interfering conditions during screening that affect the assessment of knee joint pain, including but not limited to: • Pain in any part of the lower limbs or back equal to or stronger than the target knee pain; • Pain radiating to other areas involving the knee joint, such as hip joint pain or radicular pain affecting the knee; • Chronic widespread pain (including neuropathic pain); 10. Plan to undergo surgery (excluding minor procedures) or any other procedure requiring the use of prohibited medications during the trial period; 11. Currently using medical cannabis or opioids; 12. History of bariatric surgery or device therapy (excluding liposuction, abdominoplasty, or cryolipolysis performed more than 1 year prior to screening; excluding removal or drainage of gastric intraluminal balloons for over 180 days before screening), or planned bariatric surgery during the study period; 13. Exclude participants with a reported weight change exceeding 5% within the 3 months prior to screening; 14. Exclude those who have used any weight-loss drugs, antidiabetic medications, or drugs that may cause significant weight gain within the past three months; 15. A history of previously diagnosed diabetes (excluding gestational diabetes), ketoacidosis, or hyperosmolar state/coma; 16. During screening, local laboratory tests showed glycated hemoglobin (HbA1c) >=6.5% or fasting blood glucose >=7.0 mmol/L; 17. Participants with uncontrolled hyperthyroidism or hypothyroidism, except those who had received stable-dose thyroid hormone replacement therapy for at least 3 months before screening and whose thyroid function tests (thyroid-stimulating hormone [TSH]/free triiodothyronine [FT3]/free thyroxine [FT4]) were within the normal range; 18. A personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2, or the presence of thyroid nodules classified as TI-RADS category 4 or higher; 19. History of major cardiovascular and cerebrovascular diseases, defined as: • Screening for a history of myocard
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body weight;WOMAC Pain Subscale Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| SF-36v2 Physical Functioning Score;WOMAC Physical Function Subscale Score;Volume and thickness of knee cartilage;Body weight;Vital signs, physical examination, 12 lead electrocardiogram (ECG);WOMAC Pain Subscale Score;Proportion of participants using painkillers;Adverse Events (AE);FPG?HbA1c? Fasting insulin, fasting C-peptide, and homeostasis model insulin resistance index (HOMA-IR);Neck circumference, waist circumference, hip circumference, waist to hip ratio, waist to height ratio;The allowable dosage of painkillers used during the elution period;Clinical laboratory examination indicators;Walking distance during the 6-minute walking test;Blood pressure;Blood lipid;Proportion of participants using allowed painkillers during the washout period;PGI-S, PGI-C - Target Knee Function Scores;Body Mass Index (BMI);The dosage of painkillers used; | — |
Countries
China
Contacts
Public ContactWeihua Xu
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed